PREMO Study: to Investigate Port REMoval Outcomes

NCT03948958 | Completed

• 1 other identifier: S62321
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A Totally Implantable Venous Access Device (TIVAD) that is no longer in use for intravenous therapy, should be flushed at established intervals to promote and maintain patency. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. This exploratory study will focus on catheter status under the current 3-monthly flush regimen.

Conditions

Neoplasms; Cystic Fibrosis

Keywords

Vascular Access Devices; Implantable port; Flush interval; Catheter function; Catheter-related infection; Catheter tip location; Catheter tip thrombus; Catheter sleeve; Patient-reported outcome measure

Outcome Measures

Primary Outcomes (1)

• TIVAD function

  will be assessed in terms of both injection and aspiration abilities. The ability is scored as easy, difficult or impossible along the Catheter Injection and Aspiration (CINAS) classification.

  during the 1 day of TIVAD removal, before the linogram

Secondary Outcomes (3)

• Catheter tip position visualization by fluoroscopy

  during the 1 day of TIVAD removal, just before the linogram

• Port chamber filling, sleeve formation, sleeve extend, catheter tip thrombosis and damage in port chamber or catheter trajectory

  during the 1 day of TIVAD removal

• Catheter tip and port chamber culture

  during the 1 day of TIVAD removal (following TIVAD removal)

Other Outcomes (1)

• Patient-reported outcome measure

  during the 1 day of TIVAD removal

Study Arms (1)

TIVAD evaluation

EXPERIMENTAL

TIVAD evaluation at port removal evaluation of catheter function, visualization of catheter tip, presence of thrombus material and sleeve and any device damage during linogram (contrast injection via TIVAD), tip and chamber content microbiological culture, macroscopic catheter and port chamber evaluation PROM: patient reported outcome measurements regarding TIVAD insertion, presence and removal

Other: Evaluation of the catheter function; Other: Catheter tip location, thrombus, sleeve and device damage visualization; Other: Catheter-related colonization; Other: patient-reported outcome measures (PROM) related to the presence of the TIVAD; Other: Macroscopic evaluation of the port chamber and catheter

Interventions

Evaluation of the catheter function OTHER

Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)

TIVAD evaluation

Catheter tip location, thrombus, sleeve and device damage visualization OTHER

Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram

TIVAD evaluation

Catheter-related colonization OTHER

TIVAD colonization will be investigated by microbiological culture of the tip and chamber content

TIVAD evaluation

patient-reported outcome measures (PROM) related to the presence of the TIVAD OTHER

PROM will evaluate patient's experiences regarding the TIVAD insertion, dwell time, and removal using the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire.

TIVAD evaluation

Macroscopic evaluation of the port chamber and catheter OTHER

Macroscopic evaluation of the port chamber and catheter will be performed after port removal.

TIVAD evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of 18 years and older, with a TIVAD that is no longer used for intravenous therapy on a regular basis for the past 365 days after completing initially planned treatment.
• Patients planned for an elective TIVAD removal under local anaesthesia.
• Patients able to participate in the study and willing to sign an informed consent.
• Patients able to understand and read Dutch.

You may not qualify if:

• History of fever and/or chills following last flushing procedure

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• B. Braun Medical SA: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (19)

• Goossens GA, Jerome M, Janssens C, Peetermans WE, Fieuws S, Moons P, Verschakelen J, Peerlinck K, Jacquemin M, Stas M. Comparing normal saline versus diluted heparin to lock non-valved totally implantable venous access devices in cancer patients: a randomised, non-inferiority, open trial. Ann Oncol. 2013 Jul;24(7):1892-1899. doi: 10.1093/annonc/mdt114. Epub 2013 Apr 3.

  PMID: 23553060 BACKGROUND

• Odabas H, Ozdemir NY, Ziraman I, Aksoy S, Abali H, Oksuzoglu B, Isik M, Civelek B, Dede D, Zengin N. Effect of port-care frequency on venous port catheter-related complications in cancer patients. Int J Clin Oncol. 2014 Aug;19(4):761-6. doi: 10.1007/s10147-013-0609-7. Epub 2013 Aug 27.

  PMID: 23978939 BACKGROUND

• Palese A, Baldassar D, Rupil A, Bonanni G, Capellari Maria T, Contessi D, De Crignis L, Vidoni A, Piller Roner S, Zanini A. Maintaining patency in totally implantable venous access devices (TIVAD): a time-to-event analysis of different lock irrigation intervals. Eur J Oncol Nurs. 2014 Feb;18(1):66-71. doi: 10.1016/j.ejon.2013.09.002. Epub 2013 Oct 4.

  PMID: 24100090 BACKGROUND

• Diaz JA, Rai SN, Wu X, Chao JH, Dias AL, Kloecker GH. Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports. J Oncol Pract. 2017 Jan;13(1):e22-e28. doi: 10.1200/JOP.2016.010843. Epub 2016 Oct 23.

  PMID: 28084883 BACKGROUND

• Dal Molin A, Guerretta L, Mazzufero F, Rasero L. The management of totally implanted venous ports in the ambulatory oncologic patient. J Vasc Access. 2009 Jan-Mar;10(1):22-6. doi: 10.1177/112972980901000104.

  PMID: 19340795 BACKGROUND

• Goossens GA. Flushing and Locking of Venous Catheters: Available Evidence and Evidence Deficit. Nurs Res Pract. 2015;2015:985686. doi: 10.1155/2015/985686. Epub 2015 May 14.

  PMID: 26075094 BACKGROUND

• Ferroni A, Gaudin F, Guiffant G, Flaud P, Durussel JJ, Descamps P, Berche P, Nassif X, Merckx J. Pulsative flushing as a strategy to prevent bacterial colonization of vascular access devices. Med Devices (Auckl). 2014 Nov 7;7:379-83. doi: 10.2147/MDER.S71217. eCollection 2014.

  PMID: 25404862 BACKGROUND

• Gristina AG, Giridhar G, Gabriel BL, Naylor PT, Myrvik QN. Cell biology and molecular mechanisms in artificial device infections. Int J Artif Organs. 1993 Nov;16(11):755-63.

  PMID: 8150521 BACKGROUND

• Douard MC, Arlet G, Longuet P, Troje C, Rouveau M, Ponscarme D, Eurin B. Diagnosis of venous access port-related infections. Clin Infect Dis. 1999 Nov;29(5):1197-202. doi: 10.1086/313444.

  PMID: 10524963 BACKGROUND

• Brouns F, Schuermans A, Verhaegen J, De Wever I, Stas M. Infection assessment of totally implanted long-term venous access devices. J Vasc Access. 2006 Jan-Mar;7(1):24-8. doi: 10.1177/112972980600700105.

  PMID: 16596525 BACKGROUND

• Tang S, Beigel R, Arsanjani R, Larson B, Luthringer D, Siegel R. Infective Endovascular Fibrin Sheath Vegetations-A New Cause of Bacteremia Detected by Transesophageal Echocardiogram. Am J Med. 2015 Sep;128(9):1029-38. doi: 10.1016/j.amjmed.2015.03.019. Epub 2015 Apr 10.

  PMID: 25865922 BACKGROUND

• Onal B, Coskun B, Karabulut R, Ilgit ET, Turkyilmaz Z, Sonmez K. Interventional radiological retrieval of embolized vascular access device fragments. Diagn Interv Radiol. 2012 Jan-Feb;18(1):87-91. doi: 10.4261/1305-3825.DIR.4098-10.1. Epub 2011 Feb 8.

  PMID: 21305467 BACKGROUND

• Kojima S, Hiraki T, Gobara H, Iguchi T, Fujiwara H, Matsui Y, Mitsuhashi T, Kanazawa S. Fracture of totally implanted central venous access devices: a propensity-score-matched comparison of risks for Groshong silicone versus polyurethane catheters. J Vasc Access. 2016 Nov 2;17(6):535-541. doi: 10.5301/jva.5000606. Epub 2016 Oct 21.

  PMID: 27768210 BACKGROUND

• Goossens GA, De Waele Y, Jerome M, Fieuws S, Janssens C, Stas M, Moons P. Diagnostic accuracy of the Catheter Injection and Aspiration (CINAS) classification for assessing the function of totally implantable venous access devices. Support Care Cancer. 2016 Feb;24(2):755-761. doi: 10.1007/s00520-015-2839-x. Epub 2015 Jul 26.

  PMID: 26209949 BACKGROUND

• Bouza E, Martin-Rabadan P, Echenagusia A, Camunez F, Rodriguez-Rosales G, Simo G, Echenagusia M, Guembe M; GEIDI study group. Diagnosis of venous access port colonization requires cultures from multiple sites: should guidelines be amended? Diagn Microbiol Infect Dis. 2014 Feb;78(2):162-7. doi: 10.1016/j.diagmicrobio.2013.11.004. Epub 2013 Nov 14.

  PMID: 24316016 BACKGROUND

• Marcy PY, Dahlet C, Brenet O, Yazbec G, Dubois PY, Salm B, Fouche Y, Mari V, Montastruc M, Lebrec N, Ancel B, Paillocher N, Dupoiron D, Rangeard O, Michel C, Chateau Y, Ettaiche M, Ferrero JM, Chamorey E. [Multicenter validation study of a questionnaire assessing patient satisfaction with and acceptance of totally-implanted central venous access devices]. Bull Cancer. 2015 Apr;102(4):301-15. doi: 10.1016/j.bulcan.2015.02.012. Epub 2015 Mar 21. French.

  PMID: 25799876 BACKGROUND

• Goossens GA, Vrebos M, De Wever I, Stas M. Vacutainer filling time through subcutaneous venous access devices. J Vasc Access. 2004 Oct-Dec;5(4):154-60. doi: 10.1177/112972980400500404.

  PMID: 16596559 BACKGROUND

• Goossens GA, Douchy T, Jerome M, Peeters Y, Hompes D, Boecxstaens V. Port REMoval Outcomes (PREMO) study: Patients' experiences with a Totally Implantable Venous Access Device: A questionnaire at device removal. J Vasc Access. 2025 May 27:11297298251340461. doi: 10.1177/11297298251340461. Online ahead of print.

  PMID: 40421915 DERIVED

• Douchy T, Hompes D, Maleux G, Jerome M, Peeters Y, Goossens GA, Boecxstaens V. Port REMoval Outcomes (PREMO) study: A pilot study for functional, microbial, radiological, and macroscopic assessment of totally implantable venous access devices. J Vasc Access. 2025 May 13:11297298251335416. doi: 10.1177/11297298251335416. Online ahead of print.

  PMID: 40359084 DERIVED

MeSH Terms

Conditions

Neoplasms; Cystic Fibrosis; Catheter-Related Infections

Interventions

Blood Coagulation; Patient Reported Outcome Measures; Catheters

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Infections

Intervention Hierarchy (Ancestors)

Hemostasis; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Equipment and Supplies

Study Officials

• Marguerite Stas, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: June 28, 2019
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)